A Randomized Controlled Trial to Evaluate Feasibility of Bundled HCV/HIV Rapid Screening
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 478
- Locations
- 2
- Primary Endpoint
- HIV Test Acceptance
Study Overview
Brief Summary
This randomized controlled trial was implemented to evaluate the effect of integrating rapid Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults in a New York City Emergency Department participated in the study. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public Health Advocates approached eligible patients in the Emergency Department, performed HIV and HCV raid testing, and delivered test results to participants with post-test counseling. The primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether the addition of an HCV test adversely impacted participants' consent to test for HIV. Questionnaires were also distributed to participants to assess HCV knowledge.
Detailed Description
The high prevalence of HIV and HCV co-infection, similarity in testing strategies, and interrelated risk factors suggest a practical overlap in integrating screening services. This integration could effectively utilize existing resources and infrastructure to address both epidemics and facilitate the linkage of HCV-infected individuals to care.
The objective of this study was to integrate rapid HCV testing into a well-established HIV testing and counseling program to evaluate the effect of rapid bundled screening on HIV test acceptance rate. Secondary outcomes include HCV test acceptance, identification of newly diagnosed HCV- and HIV-positive patients, HCV knowledge, risk assessment, and refusal reasons.
The two-armed, randomized controlled trial was conducted at Jacobi Medical Center, a Level 1 trauma and tertiary care center located in the Bronx, New York. Upon recruitment, all participants completed questionnaires that included demographic information, HCV risk assessment, and HCV knowledge questions. Participants were randomized either to the control arm or the intervention arm. The control arm was offered HIV testing only and the intervention arm was offered HIV testing concurrently with HCV testing (bundled HIV/HCV screening).
Sample size was determined using the following parameters: 1) 80% power; 2) significance level of 0.05; 3) two-sided significant test; and 4) 10% difference between groups on the acceptance of HIV testing. Using these parameters, a sample of 227 in each group was needed to test the primary outcome: acceptance of an integrated screening program for HIV and HCV infection. Groups of at least 333 were used to allow for drop-outs and protocol violations.
Patients were recruited from the adult Emergency Department (ED) at Jacobi Medical Center. Recruitment took place during a six-month period from December 2012 to May 2013, and 478 patients were enrolled in the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults 18 years of age or older
- •Speak English or Spanish
Exclusion Criteria
- •Inability to consent
- •Medically unstable as determined by healthcare provider
- •Does not speak English or Spanish
- •Known HIV and/or HCV positive
- •Already tested for HIV and/or HCV within past 6 months
Arms & Interventions
HIV Only
Those randomized to the control group were offered only an HIV test.
Intervention: HIV Screening (Other)
Bundled HCV/HIV
Those randomized to the intervention group were offered both HCV and HIV test.s
Intervention: Bundled HCV/HIV Screening (Other)
Outcomes
Primary Outcomes
HIV Test Acceptance
Time Frame: Through study completion, 6 months
Participant agreement to test for HIV with a rapid Oraquick oral swab
Secondary Outcomes
- HCV Knowledge and Risk(Through study completion, 6 months)
- Test Refusals(Through study completion, 6 months)
- HIV and HCV Incidence(Through study completion, 6 months)
- HCV Test Acceptance(Through study completion, 6 months)
Investigators
Jason Leider
Director of Adult HIV Services
New York City Health and Hospitals Corporation